Avenue® T TLIF Cage

With Integrated VerteBRIDGE® Plating

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The Avenue T TLIF cage design and self-guided, in-line delivery of the VerteBRIDGE anchoring plate combined with intuitive instrumentation allow for a minimally invasive TLIF Approach. 

  • First and only TLIF cage with integrated fixation gives surgeons full 360° approach options with VerteBRIDGE plating
  • Anterior column fixation opens opportunities for less invasive posterior fixation
  • Optimized and ergonomic instrumentation allows for the insertion of the cage and single-step anchoring plate deployment which may reduce operative time
  • VerteBRIDGE Plating Technology
    • Beveled & curved design allows easy penetration of the half-anchoring plates directly into the axis of the disc space in one single step in order to stabilize the vertebral segment
    • L-shaped half-anchoring plates maximize contact area in the frontal and sagittal plane optimizing bone anchorage
    • Half-anchoring plates are secured to the implant using integrated nitinol locking pins

Device Description

The Avenue T implants are devices whose primary functions are to add a solid structure to a graft so as to enable the stabilization of intervertebral height, after discectomy, during the time of graft setting and achieve a maximum surface of fusion. Various sizes of these implants are available, so that adaptations can be made to take into account the pathology and individual patient anatomy. In addition, so as to favor bone growth, the Avenue T TLIF Cage must be filled with bone graft.

 

Indications for Use

The Avenue T TLIF Cage System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.

Contraindications

Contraindications include, but are not limited to:

  • Patients under treatment inhibiting bone fusion.
  • Cardiac Problems
  • Abuse of medicine, drugs, tobacco or alcohol (which change the ossification power).
  • Material sensitivity, documented or suspected.
  • Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in post-operative care.
  • Bony abnormalities or bone stock compromised by disease (such as osteopenia, osteoporosis), infection or prior implantation preventing safe support and/or fixation to the implant.
  • Morbid obesity can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself.
  • Recent infection, fever or hyper-leukocytosis.
  • Open wounds.
  • Patients having inadequate tissue coverage over the operative site.
  • Pregnancy.
  • Inflammation.
  • Other medical (for example: anesthetics risks) or surgical conditions which would preclude the potential benefit of spinal implant surgery such as the presence of bone tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases.

 

Warnings

  • Potential risks associated with the use of this system, which may require additional surgery, include device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
  • Implants damaged in any way that can affect their form or functioning must not be implanted.
  • Under no circumstances may the implants be re-used. Although the device may appear intact on removal, internal modification due to the stress and strains placed on it, or small defects may exist which may lead to fracture of the implant.
  • Implants removed from a patient that contact bodily tissues or fluids should never be reused at risk of contamination of the patient.
  • Devices cannot withstand activity and loads equal to those placed on normal healthy bone. Until arthrodesis of segment(s) is confirmed, do not subject this device to the stress of heavy loads, or implant failure may result.
  • Mixing Metal: Some degree of corrosion occurs on all implanted metal and alloys. Contact of dissimilar metals (e.g. stainless steels and titanium), however, may accelerate this corrosion process. The presence of corrosion may accelerate fatigue fracture of implants and the amount of metal compounds released into the body system may also increase.
  • Manufacturers employ different materials, manufacturing specifications and differing design parameters. Components of the Avenue T TLIF Cage system should not be used in conjunction with components from any other manufacturer.
  • The device can break if it is subjected to increased loading associated with delayed union or non-union. If healing is delayed or does not occur, the implant could eventually break due to material fatigue. Factors, such as the patient weight, activity level, and compliance to weight bearing or load bearing instructions, have an effect in the stresses to which the implant may be subjected, and may affect the longevity of the implant.
  • Any decision by a surgeon to remove the device should take into consideration such factors as the risk to the patient of the additional surgical procedure as well as the difficulty of removal.
  • Implant removal should be followed by adequate postoperative management to avoid fracture.
  • Before implanting the Avenue T TLIF Cage, the vertebral plates must be carefully prepared, being careful not to weaken the cortical bone to avoid implant subsidence.
  • The setting and possible repositioning of the Avenue T TLIF Cage must be done with the cage holder attached to the cage.
  • Do not attempt to reposition the implant after anchoring plates have been deployed into the vertebral endplates.
  • As the Avenue T implants must be used with supplemental fixation, close attention should be paid during the insertion of the anchoring plates, in order to limit risk of contact between the anchoring plates and additional spinal hardware (e.g., pedicle screws).
  • The Avenue T TLIF Cage system has not been evaluated for heating or migration in the MR environment.

 

Precautions

  • Being a technically demanding procedure presenting a risk of serious injury to the patient, the implantation of intervertebral body fusion systems should be performed only by experienced spine surgeons with specific training in the use of this system and who have knowledge of the present instructions for use.
  • Based on fatigue testing results, when using the Avenue T TLIF Cage system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.
  • Patients who smoke have been shown to have an increased incidence of non-unions. Such patients should be advised of this fact and warned of the potential consequences.
  • If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.g., running, lifting of significant loads, or muscle strain), resultant forces can cause failure of the device.
  • In some cases, progression of degenerative disease may be so advanced at the time of implantation that they substantially decrease the expected useful life to the implant. In such cases, orthopedic devices may be considered only as a delaying technique or to provide temporary relief.
  • Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and limitations of the system. This device is recommended for use only by surgeons familiar with preoperative and surgical techniques, cautions and potential risks associated with spinal surgery. Knowledge of surgical techniques, proper reduction, selection and placement of implants, and pre- and post-operative patient management are considerations essential to a successful surgical outcome.
    • Instructions for patient care following treatment should be provided by the surgeon or another medical professional.
  • Patients should be instructed in detail about the limitations of the implants, including but not limited to the impact of excessive loading through patient weight or activity, and should be taught to govern their activities accordingly. Avenue T implants (cages and anchoring plates) are load-sharing devices which hold a vertebra in alignment until healing occurs. If healing is delayed or does not occur, the implant could eventually break due to material fatigue.
  • Risks associated with general surgery by transforaminal approach, orthopedic surgery, and the use of general anesthesia should be explained to the patient prior to surgery.
  • Appropriate selection, placement and fixation of the spinal system components are critical factors which affect implant service life. Accordingly, strict adherence to the indications, contraindications, precautions, and warnings for this product is essential to potentially maximize service life.
  • Care must be taken to protect the components from being marred, nicked or notched as a result of contact with metal or abrasive objects. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.
  • After any surgery, it is necessary to check the proper position of the implants and to follow the evolution of the fusion using appropriate techniques.
  • For the anchoring plates, it is imperative to respect the following points:
    • During multi-level implantations, care should be taken during plate selection to minimize the possibility of interference with the adjacent plate.
    • Ensure the cage does not protrude proximally outside the intervertebral disc space to be sure that the anchoring plates are properly positioned in the vertebral body.
    • If VerteBRIDGE is used in conjunction with pedicle screws, use fluoroscopy to verify the trajectory of the anchoring plates to avoid impingement with pedicle screws.
  • Sale of this product is restricted to physicians.

Legal Manufacturer:

LDR Médical
Parc d’entreprises du Grand Troyes
Quartier Europe de l’Ouest
5 rue de Berlin
10300 Sainte-Savine, France


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For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and information on this website. To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support.